Skip to main content

Treatment of Adrenal Insufficiency in neonates- Development of a Hydrocortisone Preparation for the treatment of Adrenal Insufficiency in neonatesand infants

Objective

The aim of TAIN is to develop a neonatal formulation of hydrocortisone, a drug included in the EMA priority list that needs specific evaluation in the age range 0 – 2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as replacement therapy for the treatment of congenital and acquired adrenal insufficiency as well playing an important therapeutic role in oncology in infants, specifically brain tumours and leukaemia’s. TAIN involves European leaders in neonatology, paediatric pharmacology, methodology and SMEs that will establish links with ethical bodies and regulatory authorities. The programme will perform in silico experiments and evaluate formulations for neonates. The phase 3 clinical trial comparing the neonatal hydrocortisone versus current (unlicensed) therapy will be optimized using age-appropriate state-of-the-art methods adapted to neonates (including in silico experiments and pharmacokinetics) to validate the components of a Paediatric Investigation Plan. It will be performed by neonatologists trained in paediatric pharmacology and clinical research in line with guidelines on Good Clinical Practice. All the ethical issues will be considered, including pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form will be submitted to patient and parents’ associations for approval. TAIN will include short term safety studies and Phase 3 clinical studies in neonates and infants. Results will be reported in order to allow a PUMA application to be submitted and to improve neonatal and infant care. Therefore, TAIN will validate the appropriate use of hydrocortisone in neonates and infants which will be of direct benefit to children, their families and health professionals. TAIN will strengthen paediatric drug evaluation across Europe and build up a network of units with experience in clinical research that will be used for additional drug evaluation in neonates.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmacokinetics
  • /medical and health sciences/clinical medicine/oncology
  • /medical and health sciences/basic medicine/pharmacology and pharmacy

Call for proposal

FP7-HEALTH-2011-single-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

THE UNIVERSITY OF SHEFFIELD
Address
Firth Court Western Bank
S10 2TN Sheffield
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 742 656,80
Administrative Contact
Finance Reseach

Participants (7)

CERTARA UK LIMITED
United Kingdom
EU contribution
€ 164 077,20
Address
One London Wall 6Th Floor
EC2Y 5EB London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martell Rebecca (Ms.)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 769 696,80
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Fraessdorf (Ms.)
ADD ADVANCED DRUG DELIVERY TECHNOLOGIES AG
Switzerland
EU contribution
€ 180 000
Address
Kagenstrasse 17
4153 Reinach
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Frederic Gerber (Dr.)
GLATT GMBH
Germany
EU contribution
€ 426 320
Address
Werner-glatt-strasse 1
79589 Binzen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Norbert Poellinger (Dr.)
DIURNAL LIMITED
United Kingdom
EU contribution
€ 1 659 845,20
Address
Newport Road - Eastgate House - 8Th Floor 35-43
CF24 0AB Cardiff
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ross Mcmaster (Mr.)
Genetic Alliance
United Kingdom
EU contribution
€ 75 614,40
Address
Unit 4D Leroy House , Essex Road 436
N1 3QP London
Activity type
Other
Administrative Contact
Buddug Cope (Ms.)
THE UNIVERSITY OF BIRMINGHAM
United Kingdom
EU contribution
€ 178 936,80
Address
Edgbaston
B15 2TT Birmingham
Activity type
Higher or Secondary Education Establishments
Administrative Contact
May Chung (Ms.)